Computerized Determination of Insulin Pump Therapy Parameters Using Real Time and Retrospective Data Processing

ABSTRACT

Methods and devices for providing computerized adjustment to therapy parameters using real time and retrospective data processing is provided. Embodiments include receiving a respective data set from an infusion device and an analyte monitoring device for a predetermined time duration, user notification and reminder of the predetermined time duration, time synchronizing the received respective data set, detecting one or more marked data from the one or more respective data set received, establishing one or more filtering criteria to filter of retrospective or historical data based on certain condition, performing automated data analysis based on the detected one or more marked data or the data achieving certain predetermined condition to generate a modification to a therapy profile, generating and modifying rules for profile modification, and providing the generated modification to the therapy profile for reporting and transmission.

BACKGROUND

Diabetic patients typically administer insulin to sustain theirphysiological conditions. Typically, these patients administer doses ofeither fast acting or slow acting insulin using needle type syringes,for example, prior to meals, and/or at a suitable time during the courseof each day contemporaneously with the blood glucose level testing usingfingerstick blood glucose testing, for example. If insulin is notsuitably administered, the diabetic patients risk serious if not fataldamage to the body.

Continued development and improvement in the external infusion pumptherapy in recent years have drawn much appeal to the diabetic patientsfor, among others, improved management of diabetes by better regulatingand controlling the intake of insulin. Typically, the patient inserts acannula which is connected to as infusion tubing attached to an externalpump, and insulin is administered based on a preprogrammed basalprofiles. Moreover, the external infusion devices presently availableinclude computational capability to determined suitable bolus doses suchas carbohydrate bolus and correction bolus, for example, to beadministered in conjunction with the infusion device executing thepatient's basal profile.

Commercially available infusion devices such as insulin pumps areprogrammable and include sophisticated functionalities to enhancetherapy management. Consistent with the sophistication of these devices,it is often cumbersome and trying to program these complex devices tothe desired delivery, notification, modification and/or otheradjustments or settings to be suitable for each user's physiology ortherapy.

Programming such infusion devices require the entry of many variablesand parameters, some of which are entered or provided into the devicebased, at least in part on the knowledge or experience of the userand/or the healthcare provider. For example, to modify one or more basaldelivery settings, the infusion device user may use prior knowledgebased on past experience, in addition to subjectively determinedparameters, for example, the time period for inputting measurementvalues of the blood glucose level when determining a correction bolusamount.

It goes without saying for diabetics on insulin pump therapy, continualrefinement of the basal insulin delivery rate, insulin to carbohydrateratio determination, insulin sensitivity level, duration of insulinaction, to name a few, are important in achieving successful therapymanagement. Often times, however, the refinement process is complex anditerative.

SUMMARY

Embodiments of the subject disclosure include methods device forprogramming a therapy delivery device such as a medication infusiondevice including, for example insulin pump. More particularly,embodiments of the present disclosure include receiving a respectivedata set from an infusion device and an analyte monitoring device for apredetermined time duration, time synchronizing the received respectivedata set, detecting one or more marked data from the one or morerespective data set received, performing automated data analysis basedon the detected one or more marked data or data filters to generate amodification to a therapy profile, and providing the generatedmodification to the therapy profile.

Also provided are systems, computer program products, and kits.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows a block diagram of an overall computerized adjustment totherapy parameters using real time and retrospective data processing inaccordance with one aspect;

FIG. 2 is a flowchart illustrating a routine for computerized adjustmentto therapy parameters using real time and retrospective data processingin accordance with one aspect of the present disclosure; and

FIGS. 3-14 are screen shot illustrations of the overall computerizedadjustment to therapy parameters using real time and retrospective dataprocessing in accordance with one aspect of the present disclosure.

DETAILED DESCRIPTION

Within the scope of the present disclosure, there are provided methodand system for providing automated or semi-automated computerizedadjustment to therapy parameters using real time and retrospective dataprocessing including device and/data synchronization, bi-directionalcommunication, data storage and processing, as well as providing arobust user interface. Embodiments of the present disclosure includepredetermined time period for data collection including data related tomonitored analyte levels, infusion device delivery characteristics, andevents markers, if any associated with the user. Upon expiration of thedata collection period, the information is uploaded to a data managementand analysis tool which, in one embodiment, may be configured toautomatically initiate processing of the received data, including,detecting data marked or identified for performing automatic orsemi-automatic adjustment, and output or generate a recommendedrefinement to the therapy profile, for example, which is then output tothe user or the healthcare provider or directly programmed into thetherapy delivery device.

Before the present disclosure is described in additional detail, it isto be understood that this disclosure is not limited to particularembodiments described, as such may, of course, vary. It is also to beunderstood that the terminology used herein is for the purpose ofdescribing particular embodiments only, and is not intended to belimiting, since the scope of the present disclosure will be limited onlyby the appended claims.

Where a range of values is provided, it is understood that eachintervening value, to the tenth of the unit of the lower limit unlessthe context clearly dictates otherwise, between the upper and lowerlimit of that range and any other stated or intervening value in thatstated range, is encompassed within the disclosure. The upper and lowerlimits of these smaller ranges may independently be included in thesmaller ranges is also encompassed within the disclosure, subject to anyspecifically excluded limit in the stated range. Where the stated rangeincludes one or both of the limits, ranges excluding either or both ofthose included limits are also included in the disclosure.

Unless defined otherwise, all technical and scientific terms used hereinhave the same meaning as commonly understood by one of ordinary skill inthe art to which this disclosure belongs. Although any methods andmaterials similar or equivalent to those described herein can also beused in the practice or testing of the present disclosure, the preferredmethods and materials are now described. All publications mentionedherein are incorporated herein by reference to disclose and describe themethods and/or materials in connection with which the publications arecited.

It must be noted that as used herein and in the appended claims, thesingular forms “a”, “an”, and “the” include plural referents unless thecontext clearly dictates otherwise.

The publications discussed herein are provided solely for theirdisclosure prior to the filing date of the present application. Nothingherein is to be construed as an admission that the present disclosure isnot entitled to antedate such publication by virtue of prior disclosure.Further, the dates of publication provided may be different from theactual publication dates which may need to be independently confirmed.

As will be apparent to those of skill in the art upon reading thisdisclosure, each of the individual embodiments described and illustratedherein has discrete components and features which may be readilyseparated from or combined with the features of any of the other severalembodiments without departing from the scope or spirit of the presentdisclosure.

The figures shown herein are not necessarily drawn to scale, with somecomponents and features being exaggerated for clarity.

FIG. 1 shows a block diagram of an overall therapy delivery deviceprogramming tool in accordance with one aspect of the presentdisclosure. Referring to the Figure, the system for providing automatedor semi-automated computerized adjustment to therapy parameters usingreal time and retrospective data processing 100 includes a therapydelivery device 110 such as an insulin delivery device capable of datacommunication with a controller unit 120 and a data processing terminal130. Also shown in an analyte monitoring system 140 configured forcommunication with the controller unit 120 and the data processingterminal 130. In aspects of the present disclosure, the analytemonitoring system 140 may be configured to communicate directly with thetherapy delivery device 110.

Within the scope of the present disclosure, two or more of thecomponents shown in the system 100 of FIG. 1 may be integrated into asingle device or housing. For example, the insulin delivery device 110and the analyte monitoring system 140 may be provided in a singleintegrated device housing while maintaining the separate functionalityof medication delivery and analyte monitoring, respectively.

The therapy delivery device 110 in one embodiment may include anexternal infusion device such as an external insulin pump, animplantable infusion device, an on-body micropump device, a transdermaldelivery device, or any other suitable microprocessor controlledmedication delivery device. Furthermore, the analyte monitoring system140 may include, one or more transcutaneous analyte sensors such asglucose sensors configured for fluid contact with an analyte of a userfor a predetermined time period such as for example, approximately fivedays, seven days or more.

Referring back to FIG. 1, the controller unit 120 may be configured inone aspect to perform some or all of the control functions associatedwith the operation of the insulin delivery device 110 and/or the analytemonitoring system 140. In another aspect, the control functions andoperations provided to the controller unit 120 may be to provideredundancy in operation, such that the same operations and/or controlfunctions may be provided in the respective insulin delivery device 110and/or the analyte monitoring system 140.

In one aspect, the therapy delivery device 110 may include one or moreuser interface components such as a display, input buttons, speakers forproviding audible or audio output, and the like. In one aspect, thetherapy delivery device 110 may be an ambulatory device and configuredto be carried around by the user. In still a further aspect, the therapydelivery device 110 may include a communication component which allowsthe device 110 to connect to or communicate with one or more of thecontroller unit 120 and the data processing terminal 130. Thecommunication link between the therapy delivery device 110 and the oneor more of the controller unit 120 and the data processing terminal 130may include RF communication, Infrared communication, 801.x1 basedcommunication protocol, cellular network based communication protocoland the like. In accordance with aspects of the present disclosure, thecommunication between the various components of the overall system 100shown in FIG. 1 may also includes wires connection using, for example,USB connection, RS-232 connection, or any other suitable data transferconnection.

In one aspect, the therapy delivery device 110 may be configured todeliver medication such as insulin using an infusion set connectable tothe housing of the device and in fluid communication with one or morereservoirs housed within the device 110, where the infusion set includesa cannula for medication delivery to the user or patient. In a furtheraspect, the therapy delivery device 110 is microprocessor driven andcontrolled by one or more microprocessor units to execute functionsrelated to the medication delivery, operational condition monitoring ofthe therapy delivery device, and the like.

Referring back to FIG. 1, also shown is the controller unit 120 whichmay include a wireless or wired communication device which is configuredto control at least in part, the operation of the therapy deliverydevice, and further, configured to communicate with the data processingterminal 130. Each communication link between the various componentsshown in FIG. 1 including the therapy delivery device 110, thecontroller unit 120, and the data processing terminal 130 may bebidirectional. In one aspect, the controller unit 120 may include someor all of the functionalities provided in the therapy delivery device110 including the control of the medication dispensing protocol,condition notification such as detected occlusion in the infusiontubing, and/or along the fluid path from the therapy delivery device 110to the user, programming, controlling or monitoring the operation of thetherapy delivery device 110.

Optionally, the controller unit 120 may include a strip port forreceiving an in vitro blood glucose test strip for determining a bloodglucose measurement. Additionally, the controller unit 120 may includethe functionalities of an analyte monitoring device which may beconfigured to be in communication with an analyte sensor for monitoringan analyte level of a user. Further detailed descriptions of embodimentsof the continuous analyte monitoring system, embodiments of its variouscomponents are provided in U.S. Pat. No. 6,175,752 issued Jan. 16, 2001entitled “Analyte Monitoring Device and Methods of Use”, and inapplication Ser. No. 10/745,878 filed Dec. 26, 2003 entitled “ContinuousGlucose Monitoring System and Methods of Use”, each assigned to theAssignee of the present application, disclosure of each of which areincorporated by reference for all purposes.

Referring back to FIG. 1, the data processing terminal 130 in one aspectmay include a personal computer, a portable computer such as a laptop ora handheld device (e.g., personal digital assistants (PDAs), telephonessuch as a cellular phones (e.g., a multimedia and Internet-enabledmobile phone such as an iPhone or a Blackberry device), mp3 players,pagers, and the like), each of which may be configured for datacommunication with the delivery device 110 and/or the controller unit120 via wired or wireless connection. Additionally, the data processingterminal 130 may further be connected to a data network (not shown) forstoring, retrieving, updating, and/or analyzing data associated with thetherapy delivery device 110 as well as the controller unit 120.

In this manner, in accordance with aspects of the present disclosure,data collected or monitored by the insulin delivery device 110, thecontroller unit 120 and/or the analyte monitoring system 140 is providedto the data processing terminal 130 which in turn, may be configured toperform, automatically or semi-automatically, processing of thecollected and received data, to modify the therapy management profile torecommend to the user and for execution by the insulin delivery 110 toimprove glycemic control. That is, in one aspect, the data processingterminal 130 may be configured to include software or programming toreceive data associated with insulin delivery and time correspondingmonitored analyte levels from the delivery device 110 and the analytemonitoring system 140, respectively, and automatically orsemi-automatically, with one or more user inputs or prompts, executedata analysis and therapy recommendation procedure or routine.

FIG. 2 is a flowchart illustrating a routine for computerized adjustmentto therapy parameters using real time and retrospective data processingin accordance with one aspect of the present disclosure. Referring tothe Figure, after a predetermined time has elapsed, the data processingterminal 130 may be configured to initiate communication with thedevices in the overall system including, for example insulin deliverydevice 110, the controller unit 120 and the analyte monitoring system140 (210). The predetermined time period may be programmable and basedon, for example, a time window that is sufficiently wide to providemeaningful data for analysis and processing to determine fine tuning ofthe therapy profile or patient achieving certain targeted events asprescribed by the physician.

In one aspect, the communication between the data processing terminal130 and the devices in the system 100 may not be initiated by the dataprocessing terminal 140, but rather, established at different timeperiods when each of the insulin delivery device 110, the controllerunit 120 and the analyte monitoring system 140 is within communicationrange with the data processing terminal 140, and which may includeoverlapping but not identical time periods for each communication fromthe various devices to the data processing terminal 140. In such ascase, it is important to have the clocks or timing components in eachdevice in the system 100 to be synchronized, such that the dataprocessing terminal 130 may accurately correlate the informationreceived from each device. That is, the time base for data orinformation from each device in the system may be synchronized toprovide meaningful and accurate data.

Referring to FIG. 2, with the communication link established, the timebased data from each device is received or collected for example,representative of the time period or predetermined time periodidentified by the data processing terminal 130 (FIG. 1) for analysis(220). The data processing terminal 130 may be further configured todetect data marked for fining tuning (230) based on preliminary analysisof information received from each device. For example, instances ofhypoglycemia and/or hyperglycemia detection from the analyte monitoringsystem 140, ingesting of prescribed meal and its impact on thesubsequent detected rate of change of the analyte level, detected rateof change of the analyte levels that deviate beyond a predefined levelof tolerance, and the like, which events are correspondingly marked bythe respective devices such as the analyte monitoring system 140 andidentified as part of the data transfer from the analyte monitoringsystem 140 to the data processing terminal 130.

Similarly, data from the insulin delivery device 110 may be marked bythe device during the course of the medication delivery, and thereafterprovided to the data processing terminal 130. Examples of such markeddata may include, but is not limited to, time information associatedwith user administered bolus doses, execution of temporary basal anddelivery profiles for the same, bolus insulin amount and its impact onthe subsequent rate of change of analyte level, compliance ornoncompliance to alarm or alert conditions, and the like. In one aspect,the insulin delivery device 110 may be programmed to detect occurrenceof such event and identify data or information associated with thedetection of such occurrences and subsequently to provide thatinformation in addition to the associated data to the data processingterminal 130.

Referring back to FIG. 2, in one aspect, the data processing terminal130 (FIG. 1) is configured to perform one or more processes or routinesto analyze the detected marked data and associated information receivedfrom the insulin delivery device 110, the controller unit 120 and theanalyte monitoring system 140 (240). After processing the detectedmarked data and associated information, the data processing terminal 130may be configured to generate a therapy modification output that refinesor fine tunes the one or more aspect of the therapy managementassociated with the marked data or unmarked data if they meet certainprescribed filtering criteria (250). In one aspect, the generatedtherapy modification as well as the underlying processing may beperformed automatically by the data processing terminal 130 upondetection of the communication link with the one or more devices in thesystem 100. Alternatively, within the scope of the present disclosure,the analysis and fine tuning of the therapy profile may be initiatedbased on user prompt or command, or upon detection of a predeterminedtime period for which data from the various devices and components havebeen received so as to provide a meaningful analysis based on markeddata and associated information.

FIGS. 3-14 are screen shot illustrations of the overall computerizedadjustment to therapy parameters using real time and retrospective dataprocessing in accordance with one aspect of the present disclosure. Asshown in the Figures, during data connection and processing, the statusinformation as well as user inputtable parameters are displayed in oneembodiment as visual representation to the user. For example, FIG. 3shows a status screen during data collection or synchronization with thedelivery device 110 including, for example, search and verification ofany data marked (for example, the basal test marker events shown). Ascan be further seen from FIGS. 3-14, during the data collection,synchronization and processing routines, the data processing terminal130 may be configured to provide a step by step visual presentation ofthe information being processed and various routines being executed, andoptionally request user input or confirmation.

In another aspect, the data processing terminal 130 may be programmedwith one or more predefined filter functions and configured to identifyrelevant segments of retrospective or historical data that can be usedfor further analysis.

Accordingly, one embodiment of the present disclosure includes receivinga respective data set from an infusion device and an analyte monitoringdevice for a predetermined time duration, time synchronizing thereceived respective data set, detecting one or more marked data from theone or more respective data set received, performing automated dataanalysis based on the detected one or more marked data to generate amodification to a therapy profile, and providing the generatedmodification to the therapy profile.

The data set from the infusion device includes an executed medicationdelivery profile associated with the predetermined time duration.

The data set from the analyte monitoring device includes monitoredanalyte level associated with the predetermined time duration.

Time synchronizing the received respective data set includes aligningthe time information of each data set based on a common time base.

In one aspect, the detected one or more marked data includes anindication of a hypoglycemic event, a hypoglycemic event, a rate ofchange of analyte level exceeding a predetermined threshold level,therapy compliance information, missed analyte sensor calibration event,missed meal bolus event, frequency alarm event, and frequency of alertevent.

Further, performing the automated data analysis includes refining anexecuted therapy profile based at least in part in the data processingassociated with the marked data and related information.

Also, in one aspect, the automated data analysis is initiated inresponse to the detection of the marked data.

Also, in another respect, the automated data analysis may be initiatedin response to the data achieving a preset number of prescribed eventsto proceed with meaningful analyses.

Moreover, in a further aspect, the therapy profile includes insulintherapy profile.

Additionally included in a further embodiment is transmitting thegenerated modification to the therapy profile in response to a receivedconfirmation.

An apparatus in accordance with another aspect includes a datacommunication interface, one or more processors operatively coupled tothe data communication interface, a memory for storing instructionswhich, when executed by the one or more processors, causes the one ormore processors to receive a respective data set from an infusion deviceand an analyte monitoring device for a predetermined time duration, timesynchronize the received respective data set, detect one or more markeddata from the one or more respective data set received, performautomated data analysis based on the detected one or more marked data togenerate a modification to a therapy profile, and provide the generatedmodification to the therapy profile.

Moreover, one or more storage devices having processor readable codeembodied thereon, said processor readable code for programming one ormore processors to fine tune therapy profile in accordance with stillanother aspect may include receiving a respective data set from aninfusion device and an analyte monitoring device for a predeterminedtime duration, time synchronizing the received respective data set,detecting one or more marked data from the one or more respective dataset received, performing automated data analysis based on the detectedone or more marked data to generate a modification to a therapy profile,and providing the generated modification to the therapy profile.

The various processes described above including the processes performedby the delivery device 110, the controller unit 120, the analytemonitoring system 140, and the data processing terminal 130 (FIG. 1) inthe software application execution environment in the overall system forproviding delivery device programming tool 100 including the processesand routines described in conjunction with FIG. 2, may be embodied ascomputer programs developed using an object oriented language thatallows the modeling of complex systems with modular objects to createabstractions that are representative of real world, physical objects andtheir interrelationships. The software required to carry out theinventive process, which may be stored in the memory or storage device(not shown) of the delivery device 110, the controller unit 120, thedata processing terminal 130, and the analyte monitoring system 140 maybe developed by a person of ordinary skill in the art and may includeone or more computer program products.

Various other modifications and alterations in the structure and methodof operation of this disclosure will be apparent to those skilled in theart without departing from the scope and spirit of the embodiments ofthe present disclosure. Although the present disclosure has beendescribed in connection with particular embodiments, it should beunderstood that the present disclosure as claimed should not be undulylimited to such particular embodiments. It is intended that thefollowing claims define the scope of the present disclosure and thatstructures and methods within the scope of these claims and theirequivalents be covered thereby.

1. A method, comprising: receiving a respective data set from aninfusion device and an analyte monitoring device for a predeterminedtime duration; time synchronizing the received respective data set;detecting one or more marked data from the one or more respective dataset received; performing automated data analysis based on the detectedone or more marked data to generate a modification to a therapy profile;and providing the generated modification to the therapy profile.
 2. Themethod of claim 1 wherein the data set from the infusion device includesan executed medication delivery profile associated with thepredetermined time duration.
 3. The method of claim 1 wherein theinfusion device is configured to notify the user that the predeterminedtime duration is in effect.
 4. The method of claim 1 includingperforming automated data analysis based on detection of the occurrenceof a preset number of events and/or conditions in the retrospective dataset to generate a modification to a therapy profile.
 5. The method ofclaim 4 including providing user formulation tools to modify one or morerules or guidelines for therapy modification.
 6. The method of claim 1wherein the data set from the analyte monitoring device includesmonitored analyte level associated with the predetermined time duration.7. The method of claim 1 wherein the analyte monitoring device isconfigured to notify the user that the predetermined time duration is ineffect.
 8. The method of claim 1 wherein time synchronizing the receivedrespective data set includes aligning the time of event occurrenceinformation for associated events of each data set based on a commontime base.
 9. The method of claim 1 wherein the detected one or moremarked data includes an indication of a meal event, exercise event, drugingestion event, health state event, hypoglycemic event, hyperglycemicevent, rate of change of analyte level exceeding a predeterminedthreshold level, therapy compliance information, missed analyte sensorcalibration event, missed meal bolus event, frequency alarm event, andfrequency of alert event.
 10. The method of claim 1 wherein performingthe automated data analysis includes refining an executed therapyprofile based at least in part in the data processing associated withthe marked data and related information.
 11. The method of claim 1wherein performing the automated data analysis includes refining anexecuted therapy profile based at least in part in the data processingassociated with the pre-defined filter criteria of unmarked data. 12.The method of claim 1 wherein the automated data analysis is initiatedin response to the detection of the marked data.
 13. The method of claim1 wherein the automated data analysis is initiated in response to thedata achieving a preset number of pre-defined events or conditions. 14.The method of claim 1 wherein the therapy profile includes insulintherapy profile, glucose alarm settings, target blood glucose profile,carbohydrate ratio profile or insulin sensitivity profile.
 15. Themethod of claim 1 including transmitting the generated modification tothe therapy profile in response to a received confirmation.
 16. Themethod of claim 1 including generating or modifying one or more rulesfor generating therapy profile modification.
 17. An apparatus,comprising: a data communication interface; one or more processorsoperatively coupled to the data communication interface; and a memoryfor storing instructions which, when executed by the one or moreprocessors, causes the one or more processors to receive a respectivedata set from an infusion device and an analyte monitoring device for apredetermined time duration, time synchronize the received respectivedata set, detect one or more marked data from the one or more respectivedata set received, perform automated data analysis based on the detectedone or more marked data to generate a modification to a therapy profile,and provide the generated modification to the therapy profile.
 18. Theapparatus of claim 17 wherein the data set from the infusion deviceincludes an executed medication delivery profile associated with thepredetermined time duration.
 19. The apparatus of claim 17 wherein thememory for storing instructions which, when executed by the one or moreprocessors causes the one or more processors to issue one or morenotification to perform or prohibit performance of one or more userbased events during the predetermined time period.
 20. The apparatus ofclaim 17 wherein the data set from the analyte monitoring deviceincludes monitored analyte level associated with the predetermined timeduration.
 21. The apparatus of claim 17 wherein the memory for storinginstructions which, when executed by the one or more processors, causesthe one or more processors to align the time information of each dataset based on a common time base.
 22. The apparatus of claim 17 whereinthe detected one or more marked data includes an indication of a mealevent, exercise event, drug ingestion event, health state event,hypoglycemic event, hyperglycemic event, rate of change of analyte levelexceeding a predetermined threshold level, therapy complianceinformation, missed analyte sensor calibration event, missed meal bolusevent, frequency alarm event, and frequency of alert event.
 23. Theapparatus of claim 17 wherein the memory for storing instructions which,when executed by the one or more processors, causes the one or moreprocessors to refine an executed therapy profile based at least in partin the data processing associated with the marked data and relatedinformation.
 24. The apparatus of claim 17 wherein the memory forstoring instructions which, when executed by the one or more processors,causes the one or more processors to refine an executed therapy profilebased at least in part in the data processing associated with thepre-defined filter criteria of unmarked data.
 25. The apparatus of claim17 wherein the automated data analysis is initiated in response to thedetection of the marked data.
 26. The apparatus of claim 17 wherein thetherapy profile includes insulin therapy profile, glucose alarmsettings, target blood glucose profile, carbohydrate ratio profile, orinsulin sensitivity profile.
 27. The apparatus of claim 17 wherein thememory for storing instructions which, when executed by the one or moreprocessors, causes the one or more processors to transmit the generatedmodification to the therapy profile in response to a receivedconfirmation.
 28. The apparatus of claim 17 wherein the memory forstoring instructions which, when executive by one of more processors,causes the one or more processors to update one or more rules forgenerating therapy profile modification.
 29. One or more storage deviceshaving processor readable code embodied thereon, said processor readablecode for programming one or more processors to fine tune therapyprofile, comprising: receiving a respective data set from an infusiondevice and an analyte monitoring device for a predetermined timeduration; time synchronizing the received respective data set; detectingone or more marked data from the one or more respective data setreceived; performing automated data analysis based on the detected oneor more marked data to generate a modification to a therapy profile; andproviding the generated modification to the therapy profile.